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CLOBETASOL PROPIONATE 0.05% W/W SCALP APPLICATION

Active substance(s): CLOBETASOL PROPIONATE / CLOBETASOL PROPIONATE

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Dermovate® Scalp Application / Clobetasol Propionate 0.05%w/w Scalp Application
(clobetasol propionate)
Your medicine is known by one of the above names, but will be referred to as
Dermovate throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1) What Dermovate is and what it is used for
2) What you need to know before you use Dermovate
3) How to use Dermovate
4) Possible side effects
5) How to store Dermovate
6) Contents of the pack and other information

1) What Dermovate is and what it is used for
Dermovate Scalp Application (called ‘Dermovate’ in this leaflet) contains a
medicine called clobetasol propionate. It belongs to a group of medicines
called steroids. It helps to reduce swelling and irritation.
Dermovate is used to help reduce the redness and itchiness of certain scalp
problems. These include frequently relapsing dermatoses and psoriasis that
have not responded to milder steroid creams, ointments, lotions or scalp
applications.

2) What you need to know before you use Dermovate
Do not use Dermovate:
• if you are allergic (hypersensitive) to clobetasol propionate or any of the
other ingredients of this medicine (listed in Section 6)
• if you have a skin infection on your scalp
• on a child under 1 year of age.
Do not use if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist before using Dermovate.
Warnings and precautions
Talk to your doctor or pharmacist before using your medicine if:
• you have previously had an allergic reaction with another steroid.
• you are applying the liquid under an airtight dressing. These dressings
make it easier for the active ingredient to pass through the skin. It is
possible to accidentally end up using too much.
Do not bandage or otherwise cover the treated scalp area, unless
directed to do so by your doctor.
• If directed to cover the treated area with a dressing, make sure that the
skin is cleansed before a fresh dressing is applied to prevent infections.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the liquid to broken, damaged or thin skin.
• you are applying to a large surface area.
If an infection develops during the use of this medicine talk to your doctor or
pharmacist.
Be very careful not to get the liquid in your eyes.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using this medicine.
Children

Do not use this medicine on a child under the age of 1 year.





Avoid continuous treatment for a long period of time in children over the
age of 1 year, as their skin is thinner than adults and as a result may
absorb larger amounts.
Use on children should be limited to a few days and reviewed weekly.
Dressings or bandages should not be used on children where the scalp
application is applied.

Other medicines and Dermovate
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine, especially if you are taking ritonavir and itraconazole
medications.
Pregnancy, breast-feeding and fertility
If you are pregnant or are breast-feeding, think you may become pregnant or
are planning to have a baby ask your doctor or pharmacist for advice before
taking this medicine.

3) How to use Dermovate
Always use this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Using this medicine
• You usually put Dermovate on your scalp in the morning and at night.
This may be reduced as your scalp problem begins to get better, or
stopped when it is better.
• For use on your skin of your scalp only.
• Do not use it more often than prescribed or use it for a long time (such as
every day for many weeks or months). If you need treatment for a long
time, your doctor may decide you need to use a milder treatment.
• The germs that cause infections like warm and moist conditions under
dressings. If directed to cover the treated area with a dressing, always
clean the skin before a fresh dressing is put on to help prevent infection of
the skin beneath the dressing.
• Be very careful not to get the liquid in your eyes. Do not touch your eyes
until you have washed your hands.
• If you wash or shampoo your hair it should be dried before applying the
liquid.
• If you are applying the scalp application on someone else make sure you
wash your hands after use or wear disposable plastic gloves.
• This product is flammable. Keep the liquid away from open fire and
flames and all sources of ignition, including smoking, during
application and immediately after you’ve used it.
• Do not dry your hair with a hairdryer.
Guidance on how to apply the liquid
1. Wash your hands.
2. Unscrew the bottle cap and place the nozzle directly on the scalp that
needs treating.
3. Gently squeeze the bottle to cover the area with a thin and even layer of
liquid.
4. You can rub this liquid in, but you don’t have to.
Your scalp will feel cool until the liquid has dried.
5. Wash your hands again.
6. Do not exceed the prescribed amount.
Use in children

Do not use this medicine on children under 1 year of age.

It is especially important in children not to exceed the prescribed
amount.

A course of treatment for a child should not normally last more than a
few days, unless your doctor has told you to use it for longer. The doctor
may want to see the child every week whilst using Dermovate scalp
application.
If you use more Dermovate than you should
If you apply too much or if accidentally swallowed, it could make you ill. Talk
to your doctor or go to hospital as soon as possible.

If you forget to use Dermovate
If you forget to apply your scalp application, apply it as soon as you
remember. If it is close to the time you are next meant to apply it, wait until
this time.
Do not apply extra Dermovate to make up for a missed dose.






If you stop using Dermovate
If you use Dermovate regularly make sure you talk to your doctor before you
stop using it as your condition may get worse if stopped suddenly.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety
of this medicine

4) Possible side effects

5) How to store Dermovate

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop using Dermovate and tell your doctor immediately if:
• you find that your scalp problem gets worse, you develop a generalised
rash or your skin becomes swollen during treatment. You may be allergic
to the scalp application, have an infection or need other treatment.
• you have psoriasis and get raised bumps with pus under the skin. This
can happen during or after the treatment and is known as pustular
psoriasis.
Other side effects you may notice when using Dermovate include:
Common (may affect up to 1 in 10 people)
• a feeling of burning, pain, irritation or itching where the scalp application is
applied.
Uncommon (may affect up to 1 in 100 people)
• skin thinning, this may cause stretch marks
• blood vessels under the surface of your skin may become more
noticeable.
Very Rare (may affect up to 1 in 10,000 people)
Use of Dermovate for a long period of time, or use under an airtight dressing,
may cause the following symptoms:

increased weight

moon face, rounding of the face

obesity

skin thinning

skin wrinkling

skin dryness

changes to the colour of your skin

increased body hair

hair loss/lack of hair growth/damaged looking hair
Other very rare skin reactions that may occur are:

allergic reaction at the site of application

worsening of condition

application site irritation/pain

redness

rash or hives

if you have psoriasis you may get raised bumps with pus under the skin.

This can happen very rarely during or after treatment and is known as

pustular psoriasis

skin infection

acne
In children, also look out for the following symptoms:

delayed weight gain

slow growth
Very rare side effects that may show up in blood tests or when your doctor
gives you a medical examination:

a decrease in the level of the hormone cortisol in your blood

increased levels of sugar in your blood or urine

high blood pressure







cloudy lens in the eye (cataract)
increased pressure in the eye (glaucoma)
weakening of the bones through gradual loss of mineral (osteoporosis);
additional tests may be needed after your medical examination to
confirm if you have this condition

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date on the bottle label or carton
after (Exp). The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep away from naked flames, fires or artificial heat as the liquid is
flammable.
Do not throw away medicines via wastewater or household waste. Ask
your pharmacist how to dispose of medicines you no longer use. These
measures will help to protect the environment.

6) Contents of the pack and other information
What Dermovate contains:
• The active ingredient is clobetasol propionate 0.05%w/w.
• Dermovate scalp application also contains the following inactive
ingredients: carbomer, isopropyl alcohol, sodium hydroxide and purified
water.
What Dermovate looks like and contents of the pack
Dermovate scalp application is a clear colourless, slightly viscous liquid with a
strong odour of isopropanol in a white plastic squeeze bottle with a plastic
nozzle and a plastic cap with a tamper evident ring.
Dermovate scalp application is packed in 100ml bottles.
PL 10383/1617

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Aspen Bad Oldesloe GmbH
Industriestrasse 32-36 23843 Bad Oldesloe Germany. Procured from within
the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 03.03.2017
Dermovate® is a registered trademark of the Glaxo Group Limited, United
Kingdom.
More Information
If you have any questions or are not sure about anything, ask your doctor or
pharmacist who will advise you.
You may also be able to find out more from books in public libraries.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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